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FDA 510(k)

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

K-Number: K242916 · 2025-02-04

ApplicantLargan Medical Co., Ltd.
Decision Date2025-02-04
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a medical device manufactured by Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-02-04 under approval number K242916. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2025-02-04. It is manufactured by Largan Medical Co., Ltd.. The 510(k) number is K242916.

When was Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens approved by the FDA?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2025-02-04, under approval number K242916.

What company makes Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is manufactured by Largan Medical Co., Ltd..

What is the FDA product code for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

The FDA product code for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is LPL.

Related Clinical Trials

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Other Devices by Largan Medical Co., Ltd.

K170286Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA K182674Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia K181230Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo

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Related Devices (Code: LPL)

K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc. K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc. K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. K162596AIR OPTIX COLORSAlcon Laboratories, Inc. K161931Toricolors (hioxifilcon D) Soft Contact LensesPolydev , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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